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General MedicationsORALStandard

NORPRAMIN

DESIPRAMINE HYDROCHLORIDE

Standard Dose
25MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: 901 REQUIRED Marketing status: Prescription
Summary

Approval overview NORPRAMIN is listed in Drugs@FDA under application 014399 (NDA).

Review priority: 901 REQUIRED Marketing status: Prescription Active ingredient DESIPRAMINE HYDROCHLORIDE Form and strength TABLET;ORAL - 25MG Sponsor VALIDUS PHARMS Submission history Latest submission status date: 2025-06-24 00:00:00.

Structured Monograph

Clinical summary

Approval overview NORPRAMIN is listed in Drugs@FDA under application 014399 (NDA). Review priority: 901 REQUIRED Marketing status: Prescription Active ingredient DESIPRAMINE HYDROCHLORIDE Form and strength TABLET;ORAL - 25MG Sponsor VALIDUS PHARMS Submission history Latest submission status date: 2025-06-24 00:00:00. Submission type: SUPPL.

Monitoring

  • Marketing status: Prescription
  • Review priority: 901 REQUIRED

Interaction Notes

  • No interaction notes stored yet.